Nimesulide 200mg Tablets Technical Specification:
| Product Name: | Nimesulide 200mg Tablets |
| Brand Name: | Generic |
| Strength: | 100mg, 200mg |
| Dosage Form: | Tablet (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10S, 15S, 20S, 50S, 500S |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP, DMF, COPP, FSD and CTD Dossier |
| Therapeutic use: | NSAIDs, COX-II Inhibitor |
| Indication: | To treat acute pain, inflammation and fever |
| Storage: | Store below 30°C. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
Nimesulide 100mg Tablets
Nimesulide 200mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Nimesulide Tablets 200mg
Each Uncoated Tablet Contains:
Nimesulide BP…………………………200 mg
Excipients…………………………………Q.S.
Colour: Tartrazine
THERAPEUTIC INDICATIONS:
This medication is used to relieve pain. It relieves mild to moderate pain caused by menstrual cramps and osteoarthritis cramps, backache, post-operative pain, osteoarthritis and fever.
CAUTION & WARNING:
CAUTION:
Keep medicine out of reach of children.
Not to be used in children below 12 years of age.
Use of Nimesulide should ordinarily be restricted to 10 days. If longer clinical use is warranted, liver function test should be assessed periodically.
WARNING:
TO BE SOLD BY RETAIL ON THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER ONLY.
STORAGE & DOSAGE:
STORAGE: Store at a temperature not exceeding 30°C. Protect from direct light and moisture.
DOSAGE: As directed by the Physician.